Apparatus and method for administering a medical device prescription

ABSTRACT

Methods and devices for providing instructions to treat and for treating patients through the use of medical devices are provided. Some embodiments treat musculoskeletal conditions by providing for alignment of bones by use of bone alignment devices in accordance with instructions provided through a prescription. Other embodiments may facilitate or provide revised prescriptions in response to treatment conditions. Embodiments may also provide effective ways of communicating prescription and compliance information between patients and health care providers.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/822,993 filed May 14, 2013 and U.S. Provisional Application No.61/861,538 filed Aug. 2, 2013. The disclosures of each of theseapplications are incorporated by reference in their entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are incorporated in and form a part of thespecification, illustrate the embodiments of the invention, and togetherwith the written description serve to explain the principles,characteristics, and features of the invention. In the drawings:

FIG. 1 is a system drawing of an embodiment of a system for treating apatient.

FIG. 2 is a flowchart depicting an embodiment of a method of dynamicallyproviding instructions to transform a bone alignment device.

FIG. 3 is a screenshot of a prior art system used for aligning one ormore bones of a patient.

FIG. 4 is a screenshot of an embodiment of a portion of a system usedfor aligning one or more bones of a patient.

FIG. 5 is a depiction of a patient device displaying daily adjustmentsprescribed for a bone alignment device configured to be coupled to apatient.

FIG. 6 is a depiction of a patient device displaying multiple days of aprescription for a bone alignment device configured to be coupled to apatient.

FIG. 7 is a screenshot of an embodiment of a portion of a system usedfor aligning one or more bones of a patient illustrating a revisedprescription.

FIG. 8 is a flowchart depicting an embodiment of a method of capturingand processing an image.

FIG. 9 is a screenshot of an embodiment of a portion of a system usedfor aligning one or more bones of a patient.

FIG. 10 is a depiction of a patient device displaying a prescriptionacquisition screen.

FIG. 11 is a depiction of a patient device displaying a prescriptionacquisition screen.

FIG. 12 is a depiction of a patient device displaying a prescriptioninformation screen.

FIG. 13 is a depiction of a patient device displaying multiple days of aprescription for a bone alignment device.

FIG. 14 is a depiction of a patient device displaying multiple days of aprescription for a bone alignment device and associated coach text.

FIG. 15 is a depiction of a patient device displaying multiple days of aprescription for a bone alignment device.

FIG. 16 is a flowchart depicting an embodiment of a method of displayingvalues associated with adjustment of a medical device and graphicallyrepresenting compliance with a prescription.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following descriptions of the depicted embodiments are merelyexemplary in nature and are in no way intended to limit the invention,its application, or uses.

A system for treating a patient is illustrated in FIG. 1. The particularsystem illustrated includes a bone alignment device 1 configured to becoupled to a patient, a patient device 2 connected to a network 5, aserver computer 3 connected to the network 5, and an HCP device 4connected to the network 5. The illustrated bone alignment device 1 is asix-axis external fixator. In other embodiments, a bone alignment devicemay be any device capable of coupling to two or more bones or pieces ofbone and moving or aligning the bones or pieces of bone relative to oneanother. In yet other embodiments, a device for use in a system withinthe scope of embodiments of the invention may be any type of medicaldevice for which a set of instructions to be accomplished over apredetermined period of time, or prescription, of any type is useful forthe operation of the device.

The patient device 2 illustrated is a handheld cellular device. In otherembodiments, a patient device may be any brand or type of electronicdevice capable of executing a computer program and outputting results toa patient. For example and without limitation, a patient device may be asmartphone, a tablet computer, or any other type of electronic devicecapable of providing one or both of input and output of information. Insome embodiments, a patient device is a patient owned device. In someembodiments, a patient device is a handheld device. Such a device mayprovide ready access for input and output for a patient to whom amedical device such as the bone alignment device 1 is coupled. A patientdevice such as the patient device 2 may be distinguishable from an HCPdevice such as the HCP device 4 at least in that a patient device wouldnot necessarily require permission or interaction from an HCP in orderfor a patient to transmit or receive information regarding the patient'streatment through the patient device. A patient device such as thepatient device 2 may be connected to the network 5 by any effectivemechanism. For example and without limitation, the connection may be bywired or wireless connection through any number of routers and switches.Data may be transmitted by any effective data transmission protocol. Anypatient device of the system may include integrated or separate computerreadable media containing instructions to be executed by the patientdevice. For example and without limitation, computer readable media maybe any media integrated into the patient device such as a hard discdrive, RAM, or non-volatile flash memory. Such computer readable media,once loaded into the patient device as defined herein, may be integratedand non-transitory data storage media. Similarly, computer readablemedia may be generally separable from the patient device, such as aflash drive, external hard disc drive, CD, or DVD that is readabledirectly by the patient device or in combination with a componentconnectable to the patient device.

The network 5 may be one or more interconnected networks, whetherdedicated or distributed. Non-limiting examples include intranets, theInternet, cellular data communications networks, and switched telephonicnetworks or systems. Connections to the network 5 may be continuous ormay be intermittent, only providing for a connection when requested by asending or receiving client.

The server computer 3 is shown connected to the network 5 in FIG. 1. Theserver computer 3 may be a single computing device in some embodimentsor may itself be a collection of two or more computing devices thatcollectively function to process data as described herein. The servercomputer 3, or any of its two or more computing devices, if applicable,may connect to the network 5 through one or both of firewall and webserver software and may include one or more databases. If two or morecomputing devices or programs are used, the devices may interconnectthrough a back end server application or may connect through separateconnections to the network 5. The server computer 3 or any componentserver device of the system may include integrated or separate computerreadable media containing instructions to be executed by the servercomputer. For example and without limitation, computer readable mediamay be any media integrated into the server computer such as a hard discdrive, RAM, or non-volatile flash memory. Such computer readable media,once loaded into the server computer as defined herein, may beintegrated and non-transitory data storage media. In some embodiments, aserver computer 3 may be a storage location for information that will beeventually used by any or all of the patient device 2, the servercomputer 3, and the HCP device 4. When stored on the server computer 3,memory devices of the server computer 3, as defined herein, providenon-transitory data storage and are computer readable media containinginstructions. Similarly, computer readable media may be generallyseparable from the server computer, such as a flash drive, external harddisc drive, CD, or DVD that is readable directly by the server computeror in combination with a component connectable to the server computer 3.

The HCP device 4 is shown connected to the network 5. The HCP device 4illustrated is a desktop personal computer. In other embodiments, an HCPdevice may be any brand or type of electronic device capable ofexecuting a computer program and receiving inputs from or outputtinginformation to an HCP. For example and without limitation, an HCP devicemay be a smartphone, a tablet computer, or any other type of electronicdevice capable of providing one or both of input and output ofinformation. Such a device may provide an interface for data input,compliance monitoring, prescription modification, and communication witha patient, another HCP, or a device or system manufacturer. An HCPdevice such as the HCP device 4 may be connected to the network 5 by anyeffective mechanism. For example and without limitation, the connectionmay be by wired or wireless connection through any number of routers andswitches. Data may be transmitted by any effective data transmissionprotocol. Any HCP device of the system may include integrated orseparate computer readable media containing instructions to be executedby the HCP device. For example and without limitation, computer readablemedia may be any media integrated into the HCP device such as a harddisc drive, RAM, or non-volatile flash memory. Such computer readablemedia once loaded into the HCP device as defined herein may beintegrated and non-transitory data storage media. Similarly, computerreadable media may be generally separable from the HCP device, such as aflash drive, external hard disc drive, CD, or DVD that is readabledirectly by the HCP device or in combination with a componentconnectable to the HCP device.

A flowchart depicting an embodiment of a method of dynamically providinginstructions to transform a bone alignment device is shown in FIG. 2.Block 201 illustrates that a prescription is generated by or at thedirection of an HCP. Generation of a prescription for the bone alignmentdevice 1, for example, may be accomplished with the assistance ofsoftware provided through www.spatialframe.com, as described herein.Following input of deformity measurement information, an initial frameconfiguration, and distraction or correction rate information, softwarethat is part of the website in this example generates a prescription,subject to the review and approval of an HCP. In this embodiment, theprescription is a set of instructions to be accomplished over apredetermined period of time. Depictions of the strut settings andmounting information resulting from input of deformity and frameconfiguration information is shown in FIG. 3. The information andfunction illustrated in FIG. 3 is the same for the prior art system andthe system of the present application.

Block 202 of FIG. 2 illustrates communicating a set of instructions tobe accomplished over a predetermined period of time to a patient deviceto achieve alignment of one or more bones by adjustment of a bonealignment device coupled to a patient. As used herein, the termpredetermined period of time means a period of time that is initiallyset to accomplish a correction under the initial prescription. If aprescription is revised, a time to complete the prescription may also berevised, thereby revising the original period of time and setting arevised predetermined period of time. In the example of FIG. 1, theinstructions, or prescription, may be communicated from the servercomputer 3 over the network 5 to the patient device 2.

Following communication of a prescription to a patient device, actionsmay be accomplished on the bone alignment device and a record of thoseactions conveyed to the patient device. Actions may be taken by apatient to whom the bone alignment device is coupled, by an HCP, or byany other designee capable of performing the actions. Actions may beperformed manually or may be executed automatically on a time scheduleor in response to some other initiating activity. Recording of actionsaccomplished on the bone alignment device 1 is illustrated in FIGS. 4-6.A prescription for adjustment of struts 1-6 of a bone alignment deviceis illustrated in FIG. 4. The far right-hand column of the prescriptionshows a Status column which is designated “Done” for the first 11 daysof the prescription. FIGS. 5 and 6 show an interface on the patientdevice 2 where actions that have been accomplished are recorded. Inparticular, FIG. 5 illustrates a daily adjustment input screen whereactions taken on the bone alignment device may be recorded. In thisexample, Strut 1 has been recorded as being adjusted to 179 mm, asindicated by the checkmark on the right side of the Strut 1 row. Adepiction of a patient's prescription is illustrated in FIG. 6 in syncwith the daily adjustments shown in FIG. 5. An indication that dailyprescription actions have been completed is illustrated in FIG. 6 withregard to day 11 by illumination of a “Done” tag 25. In addition toinformation about adjustments of parts of the bone alignment device,information that may be recorded on a patient device includes but is notlimited to, one or more pictures of the bone alignment device andpatient, readings of forces being transmitted through parts of the bonealignment device, identification information associated with the bonealignment device, and subjective information from a patient to whom thebone alignment device is coupled, such as but not limited to, painexperienced by the patient. Any one or all of these types of informationmay be recorded on a patient device.

As illustrated in FIG. 2, block 203, some method embodiments includereceiving information from the patient device 2 regarding one or moreadjustments made to the bone alignment device 1. In some embodiments,receiving information from the patient device 2 includes receivinginformation input into the patient device 2 by the patient to whom thebone device is coupled. In some embodiments, receiving information fromthe patient device 2 includes receiving a notification that theprescribed adjustments for a particular time period have been completed.Receiving information may also include receiving an indication that oneor more adjustments have not been made to the bone alignment device 1 inaccordance with a set of instructions to be accomplished over apredetermined period of time. In some embodiments, receiving informationfrom the patient device 2 includes receiving information transmitted asa result of a transmission initiated from the patient device 2. Forexample, a patient device 2 may automatically push data to a servercomputer 3 when a particular day's information is input into the patientdevice 2. As shown in FIG. 6 with regard to day 11 for example, when theadjustment information for day 11 was completed, the “Done” tag 25 wasgenerated and a “Done” indication was placed in the Status column of thewebsite, as illustrated in FIG. 4.

In some embodiments, a server computer such as the server computer 3 maybe configured to receive information from the patient device 2 andmonitor for compliance with the prescription embodied in the set ofinstructions to be accomplished over a predetermined period of time. Theserver computer 3 may also generate one or more notices if informationis not received from the patient device 2 that confirms compliance withthe prescription. Such a notice may be transmitted, without limitation,to one or more of the patient device 2, the HCP device 4, e-mailaccounts, phone numbers by one or more of voice and text message, andany other effective method of communication.

Information received from a patient device may include information aboutadjustments made to parts of the bone alignment device, one or morepictures of the bone alignment device and patient, readings of forcesbeing transmitted through parts of the bone alignment device,identification information associated with the bone alignment device,and subjective information from a patient to whom the bone alignmentdevice is coupled, such as but not limited to, pain experienced by thepatient.

As shown in decision block 204 of FIG. 2, information received from apatient device requires analysis in some embodiments of the invention.The conclusion to be reached based on information received from apatient device is whether or not a prescription should be revised. Somenon-limiting examples of when a prescription should be revised arelisted below. If a bone align device has not been adjusted properly,either by mistakes made during adjustment or by noncompliance, then arevised prescription may be necessary to return a patient to a set ofinstructions that will result in a proper alignment. If a bone alignmentdevice has shifted in relation to a patient's bone or the mounting ofthe device was originally improper, then a revised prescription may benecessary. If a patient is experiencing an intolerable or unusual amountof pain, then a revised prescription with a slower rate of correctionmay be necessary. System software may include an indicator selectable ona patient device for a patient to request a change to a prescription.Depending on the reason a prescription change is being requested, an HCPmay be able to revise a prescription and provide the revisedprescription to a patient device based on information received throughthe patient device and without physically examining the patient.

In an embodiment where a bone alignment device may also be used as partof a device to monitor the healing of a bone to which the bone alignmentdevice is attached, the bone alignment device may include struts orother components that are capable of sensing forces that are beingtransmitted through the bone alignment device components. For example,where a bone is being lengthened, the percentage of force beingtransmitted through the healing bone compared with the percentage offorce being transmitted through the bone alignment device may provide anHCP with information regarding when to continue the lengthening processof the bone.

One or more pictures received from a patient device may be analyzedalone or in combination with information about adjustments of parts ofthe bone alignment device to determine if a bone alignment device isbeing adjusted in accordance with a prescription. Such pictures may betaken with the patient device or uploaded to a patient device beforeanalysis of information is conducted. Pictures may be taken fromperspectives specified by software controlling the system. For example,highlighting may be superimposed on the camera screen of a patientdevice to instruct a user from which angle and at what distance to takea picture.

In some embodiments, the patient device may be capable of displaying animage of the bone alignment device at one or more stages of adjustmentto illustrate to a patient how a bone alignment device should appear ateach stage of adjustment, respectively. Some of these embodiments mayalso include the capability to display a graphical representation of thepatient's anatomy to which the bone alignment device is coupled inrelation to the bone alignment device as it should appear at each stageof adjustment, respectively.

If the answer resulting from analysis conducted at the juncture ofdecision box 204 shown in FIG. 2 is that no revised prescription shouldbe issued, then as depicted in block 205, the original prescriptionshould be continued. If however, the answer resulting from analysisconducted is that the prescription should be revised, then as depictedin block 206, a revised prescription must be calculated. A revisedprescription may include a revised set of instructions to beaccomplished over a predetermined period of time to achieve alignment ofone or more bones by adjustment of the bone alignment device coupled tothe patient based on information received. The decision to calculate arevised prescription may be based on one or both of information receivedfrom the patient device and the discretion of a treating HCP. If arevised prescription is to be implemented, the original prescriptionmust be terminated in favor of the revised prescription. Communicationof a revised set of instructions to the patient device to enabletransformation of the bone alignment device in accordance with therevised set of instructions is illustrated in FIG. 2 by an arrow fromblock 206 to block 204.

Implementation of an example revised prescription is illustrated inFIGS. 4-7. As noted above, a prescription for adjustment of struts 1-6of a bone alignment device is illustrated in FIG. 4. The prescriptionillustrated is for a 25 day correction of a mid-shaft fracture of theright lower leg of a patient, similar to the case described in FIG. 3.As noted in the far right-hand column of the prescription, the statusfor the first 11 days of the prescription is “Done”. On day 12 (e.g.,Apr. 13, 2013), after adjusting Strut 1, as shown in FIGS. 5 and 6, theprescription was stopped. The stoppage could have been for any practicalreason, but for this example, it may be assumed that the patient wasexperiencing an unusual amount of pain with the correction. Anindication of excess pain was input into the patient device 2 and thenreceived from the patient device 2 by the server computer 3. The servercomputer 3 analyzed the information received and notified the HCPthrough the HCP device 4. The HCP, through the HCP device 4 authorized arevision of the rate of correction. The maximum safe distraction ratewas changed from 1.5 mm/day to 1.0 mm/day. A revised prescription wascalculated by the server computer 3 to be accomplished over a revisedpredetermined period of time to achieve alignment. The revisedprescription is illustrated in FIG. 7. Day 0 of the revised prescriptionis Day 12 of the original prescription (e.g., Apr. 13, 2013) and theprescription time has been extended in total by two days. The revisedprescription is also illustrated in FIG. 6 where Days 1 and 2 of therevised prescription are shown appended after Day 12 of the originalprescription. Note that the distraction rate could have been loweredmore drastically to increase the time of the revised prescription evenfurther. Additionally, adjustments could have been stopped for a periodof time and then restarted when pain had reduced acceptably. Forexample, the prescription could have been stopped at its partiallyadjusted state on Day 12 (see FIG. 5 with only Strut 1 adjusted), and arevised prescription could have been started from that point with a Day0 several days later, wherein the revised Day 0 started with the strutsettings of the partially adjusted original Day 12.

Continuing with the example case, the revised prescription may becommunicated to the patient device to enable transformation of the bonealignment device in accordance with the revised prescription. A patientor any capable person or machine with access to the information providedon the patient device could then make the adjustments to the bonealignment device in accordance with the revised prescription.

Some methods may also include placing a unique identifier on a bonealignment device such that when a unique identifier is read or inputinto the patient device, the patient device automatically logs into aserver computer configured to receive information from the patientdevice. Some similar embodiments may include instructions on the servercomputer that compare the information received from the patient deviceregarding adjustments made to the bone alignment device to informationregarding adjustment scheduled to be performed to carry out the set ofinstructions to be accomplished over a predetermined period of time.Such instructions and functionality may assist an HCP with monitoringpatient compliance with prescribe adjustments. Some similar embodimentsmay also include instructions to compare the information received fromthe patient device regarding identity and usage to registered identityand usage information. In circumstances where identity or usageinformation do not match registered identity and usage information, thenthe server computer may generate and send notices. This information maybe useful in identifying improper reuse of a single use prescriptiondevice. Notices may be sent to one or more of the server computer, thesoftware owner, and the HCP.

In some embodiments, information received from the patient device may beused to schedule clinical or follow-up visits for patients to whom abone alignment device is coupled. Such scheduling may be done on aroutine basis, may be a result of receiving data outside of certainparameters, or may be in response to particular messages received fromthe patient device.

An embodiment of the invention is a method means of changing aprescription for a bone alignment device comprising communicating aprescribed set of instructions to be accomplished over a predeterminedperiod of time to a patient device to achieve alignment of one or morebones by adjustment of the bone alignment device and receivinginformation from the patient device regarding one or more adjustmentsmade to the bone alignment device. Such a method may also include a stepfor analyzing the information received and a step for calculating arevised set of instructions to be accomplished over a predeterminedperiod of time to achieve alignment of the one or more bones and allequivalents of these steps disclosed herein. Such a method may alsoinclude communicating the revised set of instructions to the patientdevice to enable a transformation of the bone alignment device inaccordance with the revised set of instructions. Some embodiments ofsuch a method may also include a step for adjusting the bone alignmentdevice in accordance with the revised set of instructions. In variousembodiments, adjusting the bone alignment device may include one or moreof displaying instructions for adjustment, physically adjusting one ormore struts, and providing signals to mechanized struts instructing themechanized struts to adjust.

Another embodiment of the invention is a kit for use in treating apatient in accordance with a set of instructions to be accomplished overa predetermined period of time, or in other words, a prescription. Sucha kit may be offered by a medical device manufacturer that may sell orother make available a bone alignment device and one or more computerreadable media containing programs to be used to determine and reviseprescriptions related to the use of the bone alignment device. Amanufacturer or distributor may package the kit with a bone alignmentdevice separate from the one or more computer readable media, or maypackage all elements together. The computer readable media, as detailedmore specifically above, may be offered as media alone or may beintegral with one or more of the computer devices of a system fortreating a patient. The computer readable media of some embodiments isnon-transitory data storage media, regardless of on which computerdevice instructions stored on the media are ultimately executed. Forexample and without limitation, a kit may be offered that includes abone alignment device and one or more media such as a DVD, CD, or flashmemory, which include respectively or in combination the instructions ofthe first and second readable media described herein. In anothernon-limiting example, a kit may include a bone alignment device and aserver computer on which one or both of the first and second readablemedia are stored. Although the server computer may not executeinstructions that are configured to be programmed into a patient device,the server computer does constitute computer readable media by virtue ofthe fact that instructions of the first or second computer readablemedia are stored on the server computer. In addition, a devicemanufacturer may assemble or provide for assembly all elements of kitembodiments without necessarily offering the elements together tocustomers.

A kit embodiment may specifically be described to include, a bonealignment device configured to be coupled to a patient, and a firstcomputer readable media containing instructions that are configured tobe programmed into a server computer to enable the server computer totransmit information to and receive information from a patient device,and enable the server computer to calculate one or more sets ofinstructions to be accomplished over predetermined period of time. Thekit may also include a second computer readable media containinginstructions that are configured to be programmed into the patientdevice, to enable the patient device to provide information to thepatient regarding adjustment of the bone alignment device, and to enablethe patient to receive information regarding the state of the bonealignment device. In some embodiments, the prescription is transmittedby the server computer to the patient device and displayed on thepatient device, and a revised set of instructions to be accomplishedover a predetermined period of time, or in other words, a revisedprescription, may be calculated in response at least in part toinformation received regarding the state of the bone alignment device.The revised prescription may be displayed on the patient device.

In some embodiments, implementing the revised prescription results inalignment of one or more bones of the patient. For example,implementation of the prescription illustrated in FIG. 7 through thefifteenth day listed on FIG. 7 would result in alignment of thefractured tibia and fibula of the patient depicted. Such adjustments maybe accomplished by the patient to whom the bone alignment device iscoupled or by any person or mechanism cable of carrying out theinstructions of the revised prescription.

In some embodiments, the first computer readable media and the secondcomputer readable media are each part of the same physical media.

In some embodiments, the revised prescription is calculated by theserver computer and transmitted to the patient computer. In otherembodiments, the revised prescription is calculated by the patientdevice, where the patient device includes further instructionsconfiguring the patient device to calculate one or more sets ofinstructions to be accomplished over a predetermined period of time.

In some embodiments, the patient device is a patient owned device. Thepatient device may also be a handheld device.

The first computer readable media may include instructions that areconfigured to do one or more of the following:

-   -   receive a notification that the prescribed adjustment for a        particular time period have been completed;    -   receive information indicating that one or more adjustments have        not been made to the bone alignment device in accordance with        the set of instructions to be accomplished over a predetermined        period of time;    -   enable the server computer to analyze one or more of the        following to calculate the revised set of instructions to be        accomplished over a predetermined period of time: pictures of        the bone alignment device, information about adjustments of        parts of the bone alignment device, information about pain        experienced by a patient to whom the bone alignment device is        coupled, readings of forces being transmitted through parts of        the bone alignment device, and identification information        associated with the bone alignment device; and    -   enable the server computer to transmit information to a health        care provider, based on information received from the patient        device, to schedule a clinical visit for the patient to whom the        bone alignment device is coupled.

The second computer readable media may include instructions that areconfigured to enable the patient device to transmit tracking informationfrom the patient device. For example and without limitation, the patientdevice may include instructions to push data to the server computer atcertain time intervals, when particular compliance factors are met ornot met, or when certain functions are activated in the patient device,such as activating the “Done” tag 25 illustrated in FIG. 6. The firstcomputer readable media may include instructions that are configured toenable the server computer to receive tracking information from thepatient device and monitor for compliance with the prescription andgenerate a notice if tracking information is not received from thepatient device that confirms compliance with the prescription. The firstcomputer readable media may also include instruction that are configuredto enable the server computer to transmit a notice to one or both of thepatient device and a device associated with a treating health careprovider.

The second computer readable media may include instructions that areconfigured to enable the patient device to display an image of the bonealignment device at one or more stages of adjustment to illustrate to apatient how the bone alignment device should appear at each stage ofadjustment, respectively.

The second computer readable media may include instructions that areconfigured to enable the patient device to read a unique identifier onthe bone alignment device such that when the unique identifier is readby the patient device, the patient device automatically logs into theserver computer and transmits information to the server computer. Thefirst computer readable media may include instructions that areconfigured to enable the server computer to compare the informationreceived from the patient device regarding adjustments made to the bonealignment device to information regarding adjustments scheduled to beperformed to carry out the set of instructions to be accomplished over apredetermined period of time. The first computer readable media mayinclude instructions that are configured to enable the server computerto compare the information received from the patient device regardingidentity and usage to registered identity and usage information. Thefirst computer readable media may include instructions that areconfigured to enable the server computer to generate and send notices ifthe identity and usage information do not match registered identity andusage information.

A method embodiment is depicted in the flowchart of FIG. 8. In theillustrated embodiment, the method may be accomplished at amultifunction computer with an image capture mechanism. For example andwithout limitation, the multifunction computer may be the patient device2, as described herein and illustrated in FIGS. 1, 5, 6, and 10-15 or asimilar device. The image capture mechanism may be an integrated camera,scanner, or similar imaging device, or a separate but compatible imagingdevice of any effective type. In other embodiments, data may betransferred to the multifunction computer by a technology or methodother than imaging. For example and without limitation, data could betransferred by wireless signal, wired connection, pulsed optical signal,or sound.

Image capture is represented in FIG. 8 at block 801. An example imagecapture mechanism may be explained with the aid of FIGS. 9-12. A sampleprescription, as may be generated by an HCP, with or without thetechnical assistance of a device manufacturer, is shown in FIG. 9. Theprescription illustrated is generated on an improved version of thewebsite www.spatialframe.com, based on conditions under which a six-axisexternal fixator is being placed into service. The frame conditions,strut values, and other prescription information for the device shown inFIG. 9 may be encoded into a Quick Response code (“QR”) image, such asimage 91. Other embodiments may employ any effective type of encodedimage. For example and without limitation, an encoded image may be aconventional barcode, any type of two or three dimensional encodedimage, or a graphic recognizable by an imaging device that is a pointeror address for a multifunction computer. In this example, the image 91is provided by an HCP with the aid of software provided by the devicemanufacturer. Images of various embodiments may be generated by an HCPat greater or lesser degrees of participation by the HCP. The image 91is shown in FIG. 9 displayed on a computer screen of an HCP device 4(FIG. 1). However, in other embodiments, an image may be transmitted toa computer or other device at the convenience of a patient. A QR codeimage or other encoded image in such a case could be transmitted throughemail, text, social media site, or through any other effective mechanismand displayed on an electronic device for scanning by a patient with thepatient device 2 or with any multifunction computer running appropriatesoftware. In other embodiments, a QR code image or other encoded imagemay be printed on a physical medium and presented or otherwise deliveredto a patient for scanning by a patient.

The multifunction computer embodied in the patient device 2, as shown inFIGS. 10-12, has an integrated camera. To add a prescription to themultifunction computer, the “+” symbol shown in FIG. 10 is selected. Themultifunction computer illustrated in FIG. 10 also shows a form of helptext and graphics that is included in some embodiments of the discloseddevices and methods that will be referred to herein as “coach text.”Coach text may provide a user with useful information regarding theoperation of the multifunction computer. For example, here the coachtext graphically shows a user where to tap to add a prescription to thedevice and explains what will happen as a result of the tapping action.

The result of requesting to add a new prescription to the multifunctioncomputer of the present embodiment is illustrated in FIG. 11. A newscreen is opened that instructs a user to “Place a barcode inside theviewfinder rectangle to scan it.” The term barcode illustrated refers toa QR code image. In other embodiments, the image may be any effectivetype that contains information or may direct the multifunction computerto a network or other address where information is located. Continuingwith the present example, the multifunction computer embodied in thepatient device 2 of FIG. 11 may be used to scan the image 91 shown inFIG. 9 to load all or part of a prescription or address information thatcorrelates with a prescription into the multifunction computer, asillustrated in FIG. 12, and as represented in block 802 of FIG. 8. Asummary and a progress indicator of the prescription are depicted inFIG. 12 loaded into the patient device 2, thereby displaying at least aportion of the prescription on the multifunction computer. In theillustrated embodiment, scanning of the image 91 enables the patientdevice 2 to contact the server computer 3 (FIG. 1) through the network5, and the server computer 3 provides prescription details, includingall daily adjustments and surgeon contact information to the patientdevice 2. Either direct prescription information or address informationdirecting the patient device 2 to further prescription information areconsidered data specifying at least a portion of a prescription as usedherein.

Selectable action compliance areas 300 a and 300 b are illustrated inFIGS. 5, 6, 13 and 15. Each embodiment includes additional selectableaction compliance areas that correlate with each element of the medicaldevice 1 to form a set 400 a (FIG. 6), 400 b (FIGS. 13 and 15). Set 400a, 400 b groups together all of the selectable action compliance areasfor a day of an associated prescription. Each of the display areasincludes a color that correlates with a color present on an adjustableelement of the medical device 1 (FIG. 1), a value to which an adjustableelement of the medical device 1 should be adjusted, and an indicium ofcompletion that is activated when a user inputs into the computer thatthe value to which an adjustable element of the medical device 1 shouldbe adjusted in accordance with the prescription has been adjusted.Values illustrated in the example embodiments are 179 mm in selectableaction compliance area 300 a (FIGS. 5-6) and 151 mm in selectable actioncompliance area 300 b (FIGS. 13 and 15). Example indicia of completionin selectable action compliance areas 300 a, 300 b of the illustratedembodiments are a checkmark and color change in FIG. 5, an encircledcheckmark in FIG. 6, an encircled checkmark in FIG. 13, and an encircledcheckmark in FIG. 15. Indicia of completion in various embodiments maybe any one or more of a change in text, a change in font, a change incolor, an added character or symbol, and any other effective designator,sound, or activation.

In the embodiments illustrated in FIGS. 5, 6, 13 and 15, the selectableaction compliance areas 300 a, 300 b are displayed on a touch screen.Each selectable action compliance area correlates with an element of amedical device. In this example, six selectable action compliance areasin each of the embodiments correlate with one each of the six elementsof the medical device 1. When each element of the medical device 1 isadjusted in accordance with at least a portion of the prescription, theselectable action compliance area in these examples is configured to betouched and thereby selected. Specifically, when the box next to the 179mm value in the selectable action compliance area 300 a was touched,following adjustment of Strut 1 in compliance with the Day 12requirement of the prescription, the selectable action compliance area300 a was selected. When the selectable action compliance area 300 b wastouched, following adjustment of Strut 1 to 151 mm in compliance withthe Day 2 requirement of the prescription, the selectable actioncompliance area 300 b was selected. In other embodiments, selectableaction compliance areas may be selectable with any type of effectivepointing device. For example and without limitation, pointing devicesmay include a touchpad, a mouse, a rollerball, a digitizing pad, and alight emitting pointing device.

As listed in FIG. 8, block 803, method embodiments may includedisplaying selectable action compliance areas on a screen of themultifunction computer that are to be selected when one or more portionsof the prescription are completed. Method embodiments may also includeselection of selectable action compliance areas, as depicted in block804 of FIG. 8. Until selection of a selectable action compliance area isdetected, the method will continue to display the selectable actioncompliance areas. When a selectable action compliance area is selected,“Yes” at block 804, the illustrated method will check whether to reportthe selection to the HCP (block 805). If no report is to be made, themethod will return and continue to display selectable action complianceareas. If a report to an HCP is to be made (block 806), a report will bemade according to the criteria set in the associated program. Reportingto the HCP may be automatically initiated by the multifunction computerin some embodiments, or may require operator intervention in someembodiments. Automatic reporting events may include selection of one ormore of the selectable action compliance areas. For example, when eachselectable action compliance area, such as selectable action complianceareas 300 a, 300 b is selected, the multifunction computer may reportthe event to the HCP. In other embodiments, the multifunction computermay report to the HCP only after a predetermined number or set ofselectable action compliance areas are selected. For example and withoutlimitation, the multifunction computer may report to the HCP after a oneday group of selectable action compliance areas, such as set 400 a orset 400 b (FIGS. 6, 13 and 14), have been selected. Triggers forreporting to an HCP may be configurable at one or more of the patientdevice 2, the server computer 3, and the HCP device 4 (FIG. 1).

After a report to an HCP has been made, block 806 of FIG. 8, theillustrated method checks to see if the prescription selected iscomplete (block 807). If the prescription is not complete, the methodwill return and continue to display selectable action compliance areas.If the prescription is complete, the method is configured to displayfinal prescription information and report a completed prescription tothe HCP (block 808).

An embodiment of the invention is a graphical user interface on themultifunction computer with an image capture mechanism. For example, thepatient device 2 is a multifunction computer, as shown in FIG. 11. Themultifunction computer includes an image capture mechanism when aselectable image capture area is designated, and the multifunctioncomputer captures an image including data that specifies at least aportion of a prescription provided by an HCP, as discussed herein inassociation with FIGS. 9-12. The graphical user interface on themultifunction computer displays at least a portion of the prescriptionon the multifunction computer, and displays one or more of theselectable action compliance areas 300 a, 300 b, and others, on themultifunction computer that are to be selected when one or more portionsof the prescription or completed.

In the embodiments illustrated in FIGS. 5, 6, 13 and 15, the selectableaction compliance areas 300 a, 300 b are displayed on a touch screengraphical user interface. Each selectable action compliance areacorrelates with an element of a medical device. In this example, sixselectable action compliance areas in each of the embodiments correlatewith one each of the six elements of the medical device 1. When eachelement of the medical device 1 is adjusted in accordance with at leasta portion of the prescription, the selectable action compliance area inthese examples is configured to be touched and thereby selected.Specifically, when the box next to the 179 mm value in the selectableaction compliance area 300 a was touched, following adjustment of Strut1 in compliance with the Day 12 requirement of the prescription, theselectable action compliance area 300 a was selected. When theselectable action compliance area 300 b was touched, followingadjustment of Strut 1 to 151 mm in compliance with the Day 2 requirementof the prescription, the selectable action compliance area 300 b wasselected. In other embodiments, selectable action compliance areas maybe selectable with any type of effective pointing device. For exampleand without limitation, pointing devices may include a touchpad, amouse, a rollerball, a digitizing pad, and a light emitting pointingdevice.

In some embodiments, in response to detecting selection of one or moreof the selectable action compliance areas, the multifunction computerreports selection of the selectable action compliance areas to the HCP.More particularly in the illustrated embodiments, when a selectableaction compliance area is selected, programming supporting the graphicaluser interface will check whether to report the selection to the HCP. Ifno report is to be made, the graphical user interface will continue todisplay selectable action compliance areas. If a report to an HCP is tobe made, a report will be made according to the criteria set in theassociated program. Reporting to the HCP may be automatically initiatedby the multifunction computer in some embodiments, or may requireoperator intervention in some embodiments. Automatic reporting eventsmay include selection of one or more of the selectable action complianceareas on the graphical user interface. For example, when each selectableaction compliance area, such as selectable action compliance areas 300a, 300 b is selected, the multifunction computer may report the event tothe HCP. In other embodiments, the multifunction computer may report tothe HCP only after a predetermined number or set of selectable actioncompliance areas are selected. For example and without limitation, themultifunction computer may report to the HCP after a one day group ofselectable action compliance areas, such as set 400 a or set 400 b(FIGS. 6, 13 and 14), have been selected. Triggers for reporting to anHCP may be configurable at one or more of the patient device 2, theserver computer 3, and the HCP device 4 (FIG. 1).

Another embodiment of the invention is a non-transitory computerreadable storage medium storing one or more programs, the one or moreprograms comprising instructions, which when executed by a multifunctioncomputer with an image capture mechanism, cause the computer to beconfigured to capture an image provided by an HCP. For example, thepatient device 2 is a multifunction computer, as shown in FIG. 11. Themultifunction computer includes an image capture mechanism when aselectable image capture area is designated, and the multifunctioncomputer captures an image including data that specifies at least aportion of a prescription provided by an HCP, as discussed herein inassociation with FIGS. 9-12.

In response to the data specifying at least a portion of a prescription,the instructions may further cause the multifunction computer to displayat least a portion of the prescription on the multifunction computer.For example, in the embodiments illustrated in FIGS. 5, 6, 13, and 15,the selectable action compliance areas 300 a, 300 b are displayed on atouch screen of the multifunction computer. Each selectable actioncompliance area correlates with an element of a medical device. In thisexample, six selectable action compliance areas in each of theembodiments correlate with one each of the six elements of the medicaldevice 1. When each element of the medical device 1 is adjusted inaccordance with at least a portion of the prescription, the selectableaction compliance area in these examples is configured to be touched andthereby selected. Specifically, when the box next to the 179 mm value inthe selectable action compliance area 300 a was touched, followingadjustment of Strut 1 in compliance with the Day 12 requirement of theprescription, the selectable action compliance area 300 a was selected.When the selectable action compliance area 300 b was touched, followingadjustment of Strut 1 to 151 mm in compliance with the Day 2 requirementof the prescription, the selectable action compliance area 300 b wasselected. In other embodiments, selectable action compliance areas maybe selectable with any type of effective pointing device. For exampleand without limitation, pointing devices may include a touchpad, amouse, a rollerball, a digitizing pad, and a light emitting pointingdevice.

In some embodiments, instructions are provided such that in response todetecting selection of one or more of the selectable action complianceareas, the multifunction computer reports selection of the selectableaction compliance areas to the HCP. More particularly in the illustratedembodiments, when a selectable action compliance area is selected,instructions will check whether to report the selection to the HCP. Ifno report is to be made, the multifunction computer will continue todisplay selectable action compliance areas. If a report to an HCP is tobe made, a report will be made according to the criteria set in theassociated program. Reporting to the HCP may be automatically initiatedby the multifunction computer in some embodiments, or may requireoperator intervention in some embodiments. Automatic reporting eventsmay include selection of one or more of the selectable action complianceareas. For example, when each selectable action compliance area, such asselectable action compliance areas 300 a, 300 b is selected, themultifunction computer may report the event to the HCP. In otherembodiments, the multifunction computer may report to the HCP only aftera predetermined number or set of selectable action compliance areas areselected. For example and without limitation, the multifunction computermay report to the HCP after a one day group of selectable actioncompliance areas, such as set 400 a or set 400 b (FIGS. 6, 13 and 14),have been selected. Triggers for reporting to an HCP may be configurableat one or more of the patient device 2, the server computer 3, and theHCP device 4 (FIG. 1).

Another embodiment of the invention is a computer implemented method ofdisplaying values associated with adjustments of medical device elementsfor which a prescription for adjusting the medical device has beenprovided, and of graphically representing compliance of the adjustmentswith the prescription. A flowchart representative of the method isillustrated in FIG. 16. As shown in block 160 of FIG. 16, the methodincludes presenting two or more display areas in a set, each displayarea correlating with at least one adjustable element of a medicaldevice. Example display areas are illustrated in the selectable actioncompliance areas 300 a and 300 b of FIGS. 5, 6, 13 and 15. Eachembodiment includes additional selectable action compliance areas thatcorrelate with each element of the medical device 1 to form a set 400 a(FIG. 6), 400 b (FIGS. 13 and 15) of six display areas. Set 400 a, 400 bgroups together all of the selectable action compliance areas for a dayof an associated prescription. Other embodiments may include setsgrouped together by another period of time. Each of the display areasincludes a color that correlates with a color present on an adjustableelement of the medical device 1 (FIG. 1), a value to which an adjustableelement of the medical device 1 should be adjusted, and an indicium ofcompletion that is activated when a user inputs into the computer thatthe value to which an adjustable element of the medical device 1 shouldbe adjusted in accordance with the prescription has been adjusted.Values illustrated in the example embodiments are 179 mm in selectableaction compliance area 300 a (FIGS. 5 and 6) and 151 mm in selectableaction compliance area 300 b (FIGS. 13 and 15). Example indicia ofcompletion in selectable action compliance areas 300 a, 300 b of theillustrated embodiments are a checkmark and color change in FIG. 5, anencircled checkmark in FIG. 6, an encircled checkmark in FIG. 13, and anencircled checkmark in FIG. 15. Indicium of completion in variousembodiments may be any one or more of a change in text, a change infont, a change in color, an added character or symbol, and any othereffective designator, sound, or activation.

In the method illustrated in FIG. 16, the computing device at block 161checks whether or not an adjustment has been made to a display area. Ifno adjustment has been made, the method continues to present displayareas (block 160). If an adjustment has been made in an indicium ofcompletion regarding the display area then an indicium of completion isdisplayed, as illustrated in block 162. Embodiments of the method maythen include a check to determine whether all indicia of completion in aset, as defined in associated prescription, have been displayed (block163). If all indicia of completion in a set have not been displayed, themethod continues to present display areas (block 160). If all indicia ofcompletion in a set have been displayed, then the computer may display aset indicium of completion, as described in block 164. Example setindicia of completion in the illustrated embodiments include the “Done”tag 25 (FIG. 6) and the star symbol 425 (FIGS. 13 and 15). Set indiciaof completion in various embodiments may be any one or more of a changein text, a change in font, a change in color, an added character orsymbol, and any other effective designator, sound, or activation.Embodiments of the method may then check to see if the prescription iscomplete (block 165). If the prescription is not complete, then themethod continues to present display areas (block 160). If theprescription is complete then embodiments of the method will displayfinal information regarding the prescription and compliance with theprescription and may notify the HCP (block 166).

Notification of the HCP may occur at one or more stages of theprescription and may be a direct or indirect notification. Notificationmay go specifically from the patient device 2, through the network 5,and to the HCP device 4 (FIG. 1), or may be through any other effectivemode of communication, such as but not limited to, email, text, fax,social media, and letter. Notification may also be one or morefacilitated by the server computer 3 (FIG. 1), a device manufacturer, acomputer system or network manufacturer, and any other service provider.If a notification of an HCP is to be made, notice will be made accordingto the criteria set in an associated program. Notification of the HCPmay be automatically initiated by the multifunction computer in someembodiments, or may require operator intervention in some embodiments.Automatic reporting events may include activation of one or more of theindicia of completion. For example, when each display area, such asselectable action compliance areas 300 a, 300 b is selected, themultifunction computer may notify the HCP. In other embodiments, themultifunction computer may notify the HCP only after a predeterminednumber or set of indicia of completion have been activated. For exampleand without limitation, the multifunction computer may notify the HCPafter a one day group of indicia of completion (i.e., a set indicium ofcompletion, such as set 400 a or set 400 b; FIGS. 6, 13 and 14) havebeen activated. Triggers for notifying an HCP may be configurable at oneor more of the patient device 2, the server computer 3, and the HCPdevice 4 (FIG. 1).

Another embodiment of the invention is a graphical user interface for amultifunction computer with a display, the graphical user interface mayinclude two or more display areas in a set, each display areacorrelating with at least one adjustable element of a medical device.Example display areas are illustrated in the selectable actioncompliance areas 300 a and 300 b of FIGS. 5, 6, 13 and 15. Eachembodiment includes additional selectable action compliance areas thatcorrelate with each element of the medical device 1 to form a set 400 a(FIG. 6), 400 b (FIGS. 13 and 15) of six display areas. Set 400 a, 400 bgroups together all of the selectable action compliance areas for a dayof an associated prescription. Other embodiments may include setsgrouped together by another period of time. Each of the display areasincludes a color that correlates with a color present on an adjustableelement of the medical device 1 (FIG. 1), a value to which an adjustableelement of the medical device 1 should be adjusted, and an indicium ofcompletion that is activated when a user inputs into the computer thatthe value to which an adjustable element of the medical device 1 shouldbe adjusted in accordance with the prescription has been adjusted.Values illustrated in the example embodiments are 179 mm in selectableaction compliance area 300 a (FIGS. 5 and 6) and 151 mm in selectableaction compliance area 300 b (FIGS. 13 and 15). Example indicia ofcompletion in selectable action compliance areas 300 a, 300 b of theillustrated embodiments are a checkmark and color change in FIG. 5, anencircled checkmark in FIG. 6, an encircled checkmark in FIG. 13, and anencircled checkmark in FIG. 15. Indicium of completion in variousembodiments may be any one or more of a change in text, a change infont, a change in color, an added character or symbol, and any othereffective designator, sound, or activation.

The graphical user interface may also include a set indicium ofcompletion that is activated when all indicia of completion associatedwith two or more display areas in a set have been activated. When allindicia of completion in a set have been displayed, then the computermay display a set indicium of completion. Example set indicia ofcompletion in the illustrated embodiments include the “Done” tag 25(FIG. 6) and the star symbol 425 (FIGS. 13 and 15). Set indicia ofcompletion in various embodiments may be any one or more of a change intext, a change in font, a change in color, an added character or symbol,and any other effective designator, sound, or activation.

Another embodiment of the invention is a computer program productcomprising a non-transitory computer readable medium encoded withprogram instruction that, when executed by a processor in amultifunction computer, cause the processor to execute a method that mayinclude presenting two or more display areas in a set, each display areacorrelating with at least one adjustable element of a medical device.Example display areas are illustrated in the selectable actioncompliance areas 300 a and 300 b of FIGS. 5, 6, 13 and 15. Eachembodiment includes additional selectable action compliance areas thatcorrelate with each element of the medical device 1 to form a set 400 a(FIG. 6), 400 b (FIGS. 13 and 15) of six display areas. Set 400 a, 400 bgroups together all of the selectable action compliance areas for a dayof an associated prescription. Other embodiments may include setsgrouped together by another period of time. Each of the display areasincludes a color that correlates with a color present on an adjustableelement of the medical device 1 (FIG. 1), a value to which an adjustableelement of the medical device 1 should be adjusted, and an indicium ofcompletion that is activated when a user inputs into the computer thatthe value to which an adjustable element of the medical device 1 shouldbe adjusted in accordance with the prescription has been adjusted.Values illustrated in the example embodiments are 179 mm in selectableaction compliance area 300 a (FIGS. 5 and 6) and 151 mm in selectableaction compliance area 300 b (FIGS. 13 and 15). Example indicia ofcompletion in selectable action compliance areas 300 a, 300 b of theillustrated embodiments are a checkmark and color change in FIG. 5, anencircled checkmark in FIG. 6, an encircled checkmark in FIG. 13, and anencircled checkmark in FIG. 15. Indicium of completion in variousembodiments may be any one or more of a change in text, a change infont, a change in color, an added character or symbol, and any othereffective designator, sound, or activation.

Indicium of completion for the two or more display areas are displayedwhen a user inputs into the computer that the value to which anadjustable element of the medical device should be adjusted inaccordance with the prescription has been adjusted. If all indicia ofcompletion in a set have been displayed, then the computer under thepresent method embodiment displays a set indicium of completion. Exampleset indicia of completion in the illustrated embodiments include the“Done” tag 25 (FIG. 6) and the star symbol 425 (FIGS. 13 and 15). Setindicia of completion in various embodiments may be any one or more of achange in text, a change in font, a change in color, an added characteror symbol, and any other effective designator, sound, or activation.

Notification of the HCP may occur at one or more stages of theprescription and may be a direct or indirect notification. Notificationmay go specifically from the patient device 2, through the network 5,and to the HCP device 4 (FIG. 1), or may be through any other effectivemode of communication, such as but not limited to, email, text, fax,social media, and letter. Notification may also be one or morefacilitated by the server computer 3 (FIG. 1), a device manufacturer, acomputer system or network manufacturer, and any other service provider.If a notification of an HCP is to be made, notice will be made accordingto the criteria set in an associated program. Notification of the HCPmay be automatically initiated by the multifunction computer in someembodiments, or may require operator intervention in some embodiments.Automatic reporting events may include activation of one or more of theindicia of completion. For example, when each display area, such asselectable action compliance areas 300 a, 300 b is selected, themultifunction computer may notify the HCP. In other embodiments, themultifunction computer may notify the HCP only after a predeterminednumber or set of indicia of completion have been activated. For exampleand without limitation, the multifunction computer may notify the HCPafter a one day group of indicia of completion (i.e., a set indicium ofcompletion, such as set 400 a or set 400 b; FIGS. 6, 13 and 14) havebeen activated. Triggers for notifying an HCP may be configurable at oneor more of the patient device 2, the server computer 3, and the HCPdevice 4 (FIG. 1).

Similar to the coach text illustrated and described in association withFIG. 10 herein, additional coach text is shown in FIG. 14. Coach textmay provide a user with useful information regarding the operation ofthe multifunction computer. For example, here the coach text graphicallyshows a user where to activate the screen of the patient device 2 toaccomplish tasks that are currently available on the screen of thepatient device 2. For example, coach text is included in FIG. 14 thatinstructs a user how to mark a strut adjustment as complete and how toundo a designation as complete. Coach text is also provided to instructa patient in case the patient missed a day of adjustments. In addition,the coach text encourages the patient not to make a habit ofnoncompliance. The noted “skip this day” button provides a shortcut fora patient to initiate a New Total Residual within predefined limits. Thefinal coach text illustrated in FIG. 14 directs a user to a button thatallows the user to edit reminders associated with a prescription. Insome embodiments, coach text may appear automatically when the patientdevice 2 is awaiting user input. In other embodiments, coach text mayneed to be requested by a user, or may appear when a user is apparentlyhaving difficulty navigating an application.

One form of the invention is directed to a graphical user interface on amultifunction computer with an image capture mechanism, the graphicaluser interface comprising: a selectable image capture area; andselectable action compliance areas that correlate with an elements of amedical device; wherein: in response to detecting designation of theselectable image capture area, the multifunction computer captures animage including data that specifies at least a portion of a prescriptionprovided by a health care provider, displays at least a portion of theprescription on the multifunction computer, and displays one or more ofthe selectable action compliance areas on the multifunction computerthat are to be selected when one or more portions of the prescriptionare completed; and in response to detecting selection of one or more ofthe selectable action compliance areas, the multifunction computerreports selection of the selectable action compliance areas to thehealth care provider.

In one aspect of the invention, the multifunction computer captures animage generated in response to a prescription for treatment calculatedby the health care provider, and wherein the image has been displayed onan electronic device.

In another aspect of the invention, the multifunction computer capturesan image generated in response to a prescription for treatmentcalculated by the health care provider, and wherein the image has beenapplied to a physical medium.

In another aspect of the invention, the multifunction computer capturesan image of a Quick Response code.

In another aspect of the invention, the multifunction computer includesa selectable area on a touch screen, wherein the selectable actioncompliance area correlates with an element of a medical device, andwherein when the element of the medical device is adjusted in accordancewith at least a portion of the prescription, the selectable actioncompliance area is configured to be touched and thereby selected.

In another aspect of the invention, the multifunction computerautomatically initiates contact with the health care provider when eachselectable action compliance area is selected.

In another aspect of the invention, the multifunction computerautomatically initiates contact with the health care provider when apredetermined number or set of selectable action compliance areas areselected.

Another form of the invention is directed to a non-transitory computerreadable storage medium storing one or more programs that compriseinstruction, which when executed by a multifunction computer with animage capture mechanism, cause the computer to: be configured to capturean image provided by a health care provider, wherein the image includesdata specifying at least a portion of a prescription; and in response tothe data specifying at least a portion of a prescription: display atleast a portion of the prescription on the multifunction computer;display selectable action compliance areas on a screen of themultifunction computer that are to be selected when one or more portionsof the prescription are completed; and report selection of theselectable action compliance areas to the health care provider when theselectable action compliance areas are selected on the multifunctioncomputer.

In one aspect of the invention, the image provided by a health careprovider is an image generated in response to a prescription fortreatment calculated by the health care provider, and wherein the imagehas been displayed on an electronic device.

In another aspect of the invention, the image provided by a health careprovider is an image generated in response to a prescription fortreatment calculated by the health care provider, and wherein the imagehas been applied to a physical medium.

In another aspect of the invention, the image provided by a health careprovider is an image of a Quick Response code.

In another aspect of the invention, reporting selection of theselectable action compliance areas is automatically initiated by themultifunction computer when each selectable action compliance area isselected.

In another aspect of the invention, reporting selection of theselectable action compliance areas is automatically initiated by themultifunction computer when a predetermined number or set of selectableaction compliance areas are selected.

Another form of the invention is directed to a computer implementedmethod of displaying values associated with adjustments of medicaldevice elements for which a prescription for adjusting the medicaldevice has been provided, and of graphically representing compliance ofthe adjustments with the prescription, comprising: presenting two ormore display areas in a set, each display area correlating with at leastone adjustable element of a medical device, and each display areaincluding: a color that correlates with a color present on an adjustableelement of the medical device, a value to which an adjustable element ofthe medical device should be adjusted, and an indicium of completionthat is activated when a user inputs into the computer that the value towhich an adjustable element of the medical device should be adjusted inaccordance with the prescription has been adjusted; displaying theindicia of completion for the two or more display areas; and displayinga set indicium of completion when all indicia of completion associatedwith two or more display areas in a set have been activated.

In one aspect of the invention, the act of presenting two or moredisplay areas in a set includes presenting six display areas in a set.

In another aspect of the invention, the act of presenting two or moredisplay areas in a set includes displaying a set associated withprescribed adjustments for a particular period of time.

In another aspect of the invention, the particular period of time is aday.

In another aspect of the invention, the indicium of completion is acheck mark placed within an associated display area.

In another aspect of the invention, the indicium of completion is one ormore of a change in text, a change in font, a change in color, and anadded character or symbol.

In another aspect of the invention, the method further comprisesnotifying a health care provider when a user inputs into the computerthat the value to which an adjustable element of the medical deviceshould be adjusted has been adjusted.

In another aspect of the invention, the method further comprisesnotifying a health care provider when a user inputs into the computerthat a set of values to which a set of adjustable elements of themedical device should be adjusted have been adjusted.

Another form of the invention is directed to a graphical user interfacefor a multifunction computer with a display, the graphical userinterface comprising: two or more display areas in a set, each displayarea correlating with at least one adjustable element of a medicaldevice, and each display area including: a color that correlates with acolor present on an adjustable element of the medical device, a value towhich an adjustable element of the medical device should be adjusted,and an indicium of completion that is activated when a user inputs intothe computer that the value to which an adjustable element of themedical device should be adjusted in accordance with the prescriptionhas been adjusted; and a set indicium of completion that is activatedwhen all indicia of completion associated with two or more display areasin a set have been activated.

In one aspect of the invention, the two or more display areas in a setinclude six display areas in a set.

In another aspect of the invention, each set of display areas isassociated with prescribed adjustments for a particular period of time.

In another aspect of the invention, the particular period of time is aday.

In another aspect of the invention, the indicium of completion is acheck mark placed within an associated display area.

In another aspect of the invention, the indicium of completion is one ormore of a change in text, a change in font, a change in color, and anadded character or symbol.

Another form of the invention is directed to a computer program productcomprising a non-transitory computer readable medium encoded withprogram instruction that, when executed by a processor in amultifunction computer, cause the processor to execute a methodcomprising: presenting two or more display areas in a set, each displayarea correlating with at least one adjustable element of a medicaldevice, and each display area including: a color that correlates with acolor present on an adjustable element of the medical device, a value towhich an adjustable element of the medical device should be adjusted,and an indicium of completion that is activated when a user inputs intothe computer that the value to which an adjustable element of themedical device should be adjusted in accordance with the prescriptionhas been adjusted; displaying indicia of completion for the two or moredisplay areas; and displaying a set indicium of completion when allindicia of completion associated with two or more display areas in a sethave been activated.

In one aspect of the invention, the act of presenting two or moredisplay areas in a set includes presenting six display areas in a set.

In another aspect of the invention, the act of presenting two or moredisplay areas in a set includes displaying a set associated withprescribed adjustments for a particular period of time.

In another aspect of the invention, the particular period of time is aday.

In another aspect of the invention, the indicium of completion is acheck mark placed within an associated display area.

In another aspect of the invention, the indicium of completion is one ormore of a change in text, a change in font, a change in color, and anadded character or symbol.

In another aspect of the invention, the method further comprisesnotifying a health care provider when a user inputs into the computerthat the value to which an adjustable element of the medical deviceshould be adjusted has been adjusted.

In another aspect of the invention, the method further comprisesnotifying a health care provider when a user inputs into the computerthat a set of values to which a set of adjustable elements of themedical device should be adjusted have been adjusted.

Another form of the invention is directed to a kit for use in treating apatient in accordance with a set of instructions to be accomplished overa predetermined period of time, comprising: a bone alignment deviceconfigured to be coupled to a patient; a first computer readable mediacontaining instructions that are configured to: be programmed into aserver computer, enable the server computer to transmit information toand receive information from a patient device, and enable the servercomputer to calculate one or more sets of instructions to beaccomplished over a predetermined period of time; and a second computerreadable media containing instructions that are configured to: beprogrammed into the patient device, enable the patient device to provideinformation to the patient regarding adjustment of the bone alignmentdevice, and enable the patient device to receive information regardingthe state of the bone alignment device; wherein the set of instructionsto be accomplished over a predetermined period of time is transmitted bythe server computer to the patient device and displayed on the patientdevice; wherein a revised set of instructions to be accomplished over apredetermined period of time is calculated in response at least in partto information received regarding the state of the bone alignmentdevice; and wherein the revised set of instructions to be accomplishedover a predetermined period of time is displayed on the patient device.

In one aspect of the invention, implementing the revised set ofinstructions by adjustment of the bone alignment device results inalignment of one or more bones of the patient.

In another aspect of the invention, adjustment of the bone alignmentdevice is accomplished by the patient to whom the bone alignment deviceis coupled.

In another aspect of the invention, the first computer readable mediaand the second computer readable media are each part of the samephysical media.

In another aspect of the invention, the revised set of instructions iscalculated by the server computer and transmitted to the patient device.

In another aspect of the invention, the revised set of instructions iscalculated by the patient device, and wherein the patient deviceincludes further instructions configuring the patient device tocalculate one or more sets of instructions to be accomplished over apredetermined period of time.

In another aspect of the invention, the patient device is a patientowned device.

In another aspect of the invention, the patient device is a patientowned handheld device.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to receive a notification thatthe prescribed adjustments for a particular time period have beencompleted.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to receive informationindicating that one or more adjustments have not been made to the bonealignment device in accordance with the set of instructions to beaccomplished over a predetermined period of time.

In another aspect of the invention, the second computer readable mediaincludes instructions that are configured to enable the patient deviceto transmit tracking information from the patient device.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto receive tracking information from the patient device and monitor forcompliance with the set of instructions to be accomplished and generatea notice if tracking information is not received from the patient devicethat confirms compliance with the set of instructions.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto transmit a notice to the patient device.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto transmit a notice to a device associated with a treating health careprovider.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto analyze one or more of the following to calculate the revised set ofinstructions to be accomplished over a predetermined period of time:pictures of the bone alignment device, information about adjustments ofparts of the bone alignment device, information about pain experiencedby a patient to whom the bone alignment device is coupled, readings offorces being transmitted through parts of the bone alignment device, andidentification information associated with the bone alignment device.

In another aspect of the invention, the second computer readable mediaincludes instructions that are configured to enable the patient deviceto display an image of the bone alignment device at one or more stagesof adjustment to illustrate to a patient how the bone alignment deviceshould appear at each stage of adjustment, respectively.

In another aspect of the invention, the second computer readable mediaincludes instructions that are configured to enable the patient deviceto read a unique identifier on the bone alignment device such that whenthe unique identifier is read by the patient device, the patient deviceautomatically logs into the server computer and transmits information tothe server computer.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto compare the information received from the patient device regardingadjustments made to the bone alignment device to information regardingadjustments scheduled to be performed to carry out the set ofinstructions to be accomplished over a predetermined period of time.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto compare the information received from the patient device regardingidentity and usage to registered identity and usage information.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto generate and send notices if the identity and usage information donot match registered identity and usage information.

In another aspect of the invention, the first computer readable mediaincludes instructions that are configured to enable the server computerto transmit information to a health care provider, based on informationreceived from the patient device, to schedule a clinical visit for thepatient to whom the bone alignment device is coupled.

Another form of the invention is directed to a method of changing aprescription for a bone alignment device coupled to a patientcomprising: communicating a prescribed set of instructions to beaccomplished over a predetermined period of time to a patient device toachieve alignment of one or more bones by adjustment of the bonealignment device; receiving information from the patient deviceregarding one or more adjustments made to the bone alignment device; astep for analyzing the information received; a step for calculating arevised set of instructions to be accomplished over a predeterminedperiod of time to achieve alignment of the one or more bones; andcommunicating the revised set of instructions to the patient device toenable a transformation of the bone alignment device in accordance withthe revised set of instructions.

In one aspect of the invention, the method further comprises a step foradjusting the bone alignment device in accordance with the revised setof instructions.

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the invention, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the invention should not belimited by any of the above-described exemplary embodiments, but shouldbe defined only in accordance with the claims and their equivalents.

1. A method, comprising: at a multifunction computer with an imagecapture mechanism: capturing an image provided by a health careprovider, wherein the image includes data specifying at least a portionof a prescription; and in response to the data specifying at least aportion of a prescription: displaying at least a portion of theprescription on the multifunction computer; displaying selectable actioncompliance areas on a screen of the multifunction computer that are tobe selected when one or more portions of the prescription are completed;and reporting selection of the selectable action compliance areas to thehealth care provider when the selectable action compliance areas areselected on the multifunction computer.
 2. The method of claim 1 whereinthe act of capturing an image provided by a health care providerincludes capturing an image generated in response to a prescription fortreatment calculated by the health care provider, wherein the image hasbeen displayed on an electronic device and/or applied to a physicalmedium.
 3. The method of claim 1 wherein the act of capturing an imageprovided by a health care provider includes capturing an image of aQuick Response code.
 4. The method of claim 1 wherein the act ofdisplaying a selectable action compliance area on a screen includesdisplaying a selectable area on a touch screen, wherein the selectableaction compliance area correlates with an element of a medical device,and wherein when the element of the medical device is adjusted inaccordance with at least a portion of the prescription, the selectableaction compliance area is configured to be touched and thereby selected.5. The method of claim 1 wherein the act of displaying a selectableaction compliance area on a screen includes displaying an areaselectable with a pointing device, wherein the selectable actioncompliance area correlates with an element of a medical device, andwherein when the element of the medical device is adjusted in accordancewith at least a portion of the prescription, the selectable actioncompliance area is configured to be pointed to and selected.
 6. Themethod of claim 1 wherein the act of reporting selection of theselectable action compliance areas is automatically initiated by themultifunction computer when each selectable action compliance area isselected or when a predetermined number or set of selectable actioncompliance areas are selected.
 7. A method of dynamically providinginstructions to transform a bone alignment device, the methodcomprising: communicating a set of instructions to be accomplished overa predetermined period of time to a patient device to achieve alignmentof one or more bones by adjustment of a bone alignment device coupled toa patient; receiving information from the patient device regarding oneor more adjustments made to the bone alignment device; analyzing theinformation received from the patient device; calculating a revised setof instructions to be accomplished over a predetermined period of timeto achieve alignment of the one or more bones by adjustment of the bonealignment device coupled to the patient based on the informationreceived; and communicating the revised set of instructions to thepatient device to enable transformation of the bone alignment device inaccordance with the revised set of instructions.
 8. The method of claim7 wherein the act of communicating a set of instructions to beaccomplished over a predetermined period of time to a patient deviceincludes communicating the set of instructions to a patient device thatis a patient owned device and/or a handheld device.
 9. The method ofclaim 7 wherein the act of receiving information from the patient deviceincludes at least one of: receiving information input into the patientdevice by a patient to whom the bone alignment device is coupled; andreceiving information transmitted as a result of a transmissioninitiated from the patient device.
 10. The method of claim 7 wherein aserver computer configured to receive information from the patientdevice monitors for compliance with the set of instructions to beaccomplished and generates a notice if information is not received fromthe patient device that confirms compliance with the set ofinstructions.
 11. The method of claim 7 wherein the act of receivinginformation from the patient device includes receiving one or more of:pictures of the bone alignment device, information about adjustments ofparts of the bone alignment device, readings of forces being transmittedthrough parts of the bone alignment device, information about painexperienced by a patient to whom the bone alignment device is coupled,and identification information associated with the bone alignmentdevice.
 12. The method of claim 7 wherein the act of analyzing theinformation includes analyzing one or more of: pictures of the bonealignment device, information about adjustments of parts of the bonealignment device, information about pain experienced by a patient towhom the bone alignment device is coupled, readings of forces beingtransmitted through parts of the bone alignment device, andidentification information associated with the bone alignment device.13. The method of claim 7 further comprising displaying an image of thebone alignment device on the patient device at one or more stages ofadjustment to illustrate to a patient how the bone alignment deviceshould appear at each stage of adjustment, respectively.
 14. The methodof claim 7 further comprising placing a unique identifier on the bonealignment device such that when the unique identifier is read by thepatient device, the patient device automatically logs into a servercomputer configured to receive information from the patient device. 15.The method of claim 7 further comprising a health care provider usinginformation received from the patient device to schedule a clinicalvisit for the patient to whom the bone alignment device is coupled. 16.The method of claim 7 wherein the act of receiving information from thepatient device includes at least one of: receiving a notification thatthe prescribed adjustments for a particular time period have beencompleted; and receiving information indicating that one or moreadjustments have not been made to the bone alignment device inaccordance with the set of instructions to be accomplished over apredetermined period of time.
 17. The method of claim 7 wherein theinformation regarding one or more adjustments made to the bone alignmentdevice comprises a picture of the bone alignment device; and wherein themethod further comprises specifying, on the patient device, aperspective at which the picture of the bone alignment device is to betaken.
 18. The method of claim 7 wherein the patient device comprisesone of a smartphone and a tablet computer.
 19. The method of claim 10wherein the notice generated is transmitted to at least one of thepatient device, and a device associated with a treating health careprovider.
 20. The method of claim 14 wherein instructions on the servercomputer compare the information received from the patient deviceregarding adjustments made to the bone alignment device to informationregarding adjustments scheduled to be performed to carry out the set ofinstructions to be accomplished over a predetermined period of time. 21.The method of claim 14 wherein instructions on the server computercompare the information received from the patient device regardingidentity and usage to registered identity and usage information.
 22. Themethod of claim 21 wherein if the identity and usage information do notmatch registered identity and usage information, then the servercomputer generates and sends notices.
 23. The method of claim 1 whereinthe health care provider revises the prescription based upon theselected action compliance areas, and generates a revised imageincluding data specifying a revised portion of the prescription.
 24. Themethod of claim 23 further comprising capturing the revised image at themultifunction computer, and in response to the data specifying therevised portion of the prescription, displaying the revised portion ofthe prescription on the multifunction computer.
 25. The method of claim1 further comprising generating a revised prescription based upon theselected action compliance areas.
 26. The method of claim 1 wherein themultifunction computer comprises one of a smartphone and a tabletcomputer.